PRN Research Nurse - overnight, weekend, and holiday staff

About the role

The role of the study Research Nurse is to ensure patient safety and wellbeing. The Research Nurse will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic.

Responsibilities

• Ensure patient safety and wellbeing
• Perform critical patient evaluations
• Recognize logistical problems and initiate appropriate solutions
• Collaborate with various role players
• Work independently and be a team player
• Proactively problem solve
• Develop management systems and prepare for study initiation
• Assess study feasibility
• Possess a sound and in-depth understanding of each protocol
• Review inclusion/exclusion criteria, overall structure, and requirements of each protocol
• Review protocol summary sheet and Informed Consent Form
• Develop draft protocol follow-up worksheets
• Develop a mechanism for subject recruitment
• Screen and enroll study subjects
• Manage study-related activities, subject compliance, and documentation
• Ensure adherence to protocol requirements
• Schedule subjects for follow-up visits
• Assist investigators in assessment of subject response to therapy
• Review laboratory data and document
• Report to primary care provider as appropriate
• Assess and document subject compliance with medications and visits
• Communicate with pharmacy staff to assure timely and accurate study drug distribution
• Manage administration of investigational therapy
• Maintain dispensing logs (if allowed)
• Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
• Oversee specimen collection, storage, and shipment
• Attend study-related meetings as appropriate
• Communicate regularly with the principal investigator, monitor, and others responsible for conduct of the research about study-related issues
• Record data and study documentation
• Record data as directed using the appropriate media or platform
• Follow procedures for access and security for electronic data entry
• Review keyed data for accuracy, as needed
• Send data to the data collection center on a timely basis
• Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
• Correct and edit data as directed and as appropriate
• Monitor and report adverse events
• Assess, document and record all AEs as outlined in the protocol
• Report serious AEs to the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol)
• Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.)
• Ensure that all required documentation is complete and appropriately filed
• Prepare and submit reports, as required
• Manage site activities during audits and inspections
• Prepare for quality assurance audits and regulatory inspections
• Act as contact person before, during and after audits and inspections
• Provide all required documentation to auditors
• Make all appropriate corrections as requested by auditors
• Coordinate site response to audit/inspection findings
• Train and supervise support staff

Requirements

• RN/LPN with related clinical experience
• Experience working on clinical trials for a minimum of 1 year
• Knowledge of FDA regulations and GCP
• Accuracy, attention to detail and ability to set priorities and meet deadlines
• Basic Computer Skills required: Microsoft Office Suite, including Word, PowerPoint, Excel
• Minimum of 3 years of relevant experience
• Proficient in proper office etiquette and conflict resolution
• Excellent bedside manner and patient-centric focus
• Excellent time management and social skills
• Highly motivated with a phenomenal eye for detail

Benefits

No specific benefits are mentioned in the job posting.

Pay

• PRN Research Nurse: Estimated $110,316 per year
• PRN Research Assistant: Estimated $112,591 per year
• PRN Research Nurse Practitioner: Estimated $177,668 per year
• PRN EMT-P: $25.0-30.0 per hour

Schedule

• PRN Research Nurse: Overnight, weekend, and holiday staff training is done during normal business hours
• PRN Research Assistant: Overnight, weekend, and holiday staff
• PRN Research Nurse Practitioner: Overnight, weekend, and holiday staff
• PRN EMT-P: Overnight, weekend, and holiday staff